March 30, 2016

Dietary Supplements Regulated by 25-plus FDA, FTC Guidelines

Over 65 percent of Americans take dietary supplements such as vitamins, minerals, and herbs to support good health. The multi billion dollar supplement industry regularly grows by between 6 percent and 11 percent annually.

Yet the legal framework of supplements (sometimes called “nutraceuticals”) is often misunderstood. The mainstream press routinely mischaracterizes the entire supplement industry as “unregulated” or “under-regulated” or “loosely regulated.” In fact, however, supplements are under the authority of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC)—regulated by more than 25 rules, plus numerous FDA and FTC guidance documents.

The FDA and FTC are both consumer-protection agencies with the same mission: to ensure that supplements on the market are safe and beneficial.

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA), a logical statutory schema to regulate dietary supplements. The Act created and defined dietary supplements as a sub-category of foods. However, since “food supplements” are not new synthetic molecules for medicines—that is, they are not drugs— they do not require FDA premarket approval.

With DSHEA, Congress strongly endorsed dietary supplements as part of a public policy initiative to promote better health, prevent chronic diseases, and reduce health care costs. As a result of this statute and two decades of FDA rulemaking, dietary supplements sold today are subject to strict rules for: ingredients, manufacturing, safety, labeling, proper claims, reporting, and advertising. (Most regulations are in 21 C.F.R.)

To enforce safety, DSHEA authorizes the FDA to rapidly respond to any potential or actual injury to a consumer from a dietary supplement. First, the FDA may cite a supplement on grounds of “adulteration” if it contains a dietary ingredient that “presents a significant or unreasonable risk of injury” under the “conditions of use recommended or suggested” in its labeling. Second, if the FDA establishes such imminent harm, the Secretary of HHS may then declare that a supplement poses an imminent threat to human health and safety. For example, the herb Ephedra was banned from all supplements in 2004; more recently, body building supplements containing the synthetic DMAA were forbidden as “adulterated.”

Many regulations in the life of a supplement product exist to promote consumer safety. Starting with formulation, no drug ingredients are permitted; on occasion, supplements spiked with drugs have been caught as imports and then cited in FDA Warning Letters. The few intentional spiking cases are prosecuted criminally by the Department of Justice. Companies seeking to introduce new dietary ingredients since 1994 when DSHEA was enacted must submit to the FDA a safety report with guarantees of non-toxicity 75 days before marketing the new supplement.

Next, all raw ingredient suppliers must be certified, and ingredient purity and quality are double checked before manufacturing begins. For production, rigorous and comprehensive Good Manufacturing Processes (GMPs) were mandated for supplements by the FDA in 2007. Even post-market, there is a requirement: the labeler must submit a special MedWatch form to the FDA for any serious (life-threatening) Adverse Event Report received.

Yet other rules spell out specific requirements for dietary supplement labels, including the Supplement Facts box — every line of which is regulated. All dietary ingredients must be disclosed (with the amounts per serving listed), and the percent Daily Value must be declared for each vitamin and mineral. Similar to foods, supplement labels may make certain claims regarding the product’s benefits. Nutrient content claims such as “High in Magnesium” are permitted. Organic claims are allowed, depending on current organic standards and regulations issued by the USDA. Some FDA-authorized health claims are also permitted; a health claim ties a nutrient to the reduced risk of disease such as “Calcium may reduce your risk of osteoporosis.”

Unlike foods, however, DSHEA permits supplements to make “structure/function claims” in labeling and marketing. Such statements may: 1) promise benefits of general wellness; 2) provide support for a structure or function of the body (e.g., “Helps promote good circulation”); or 3) explain the mechanism of an ingredient (e.g., “This antioxidant formula helps neutralize free radicals in the body”). Claims like these must be supported by sound substantiation—either from the existing scientific and medical literature or as shown in clinical trials.

Of course, since these products are dietary supplements, and not drugs, they may never make therapeutic claims or disease claims. Thus, “Strengthens your immune system” is allowed, but not “Helps prevent colds and flu.” Indeed, one of the three conditions for making a structure/function claim is that it must be accompanied on the label by this Disclaimer: *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” (in bold type and in a box).

Proper manufacturing, labeling, and marketing of supplements are all enforced by FDA inspections that occur without prior notice. Violations are cited with a Form 483 and/or with warning letters—which are publicly posted on the Agency’s website. FDA officials also conduct “electronic surveillance” by examining the promotional websites of dietary supplements. Ultimately, for egregious violations (e.g., repeated cancer claims), the FDA has the authority to seize harmful products and essentially shut down illegal businesses. In addition, the Federal Trade Commission (FTC) monitors and rigorously regulates all supplement promotions and marketing, in any channel or medium, including TV infomerials, websites and social media. FTC prosecutions—with a focus on unsupported weight loss claims—can result in fines in the millions for both companies and their principals, which clearly have deterrent value.

Beyond federal regulations and enforcement, there are also specific state regulations. Many states have additional requirements regarding ingredients, label warnings, manufacturing practices, and advertising—with the most active AG’s located in California, New York, and Texas. False advertising is also closely monitored by the National Advertising Division of the Better Business Bureau and by the Truth in Advertising program of the Natural Products
Association.

In my FDA and FTC regulatory practice, I have helped dietary supplement clients navigate and comply with a varied network of regulations; and I have handled and defended enforcement actions in the above scenarios and jurisdictions.
So, in short, if dietary supplements were truly unregulated, then I would be collecting unemployment!

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